Job description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary:
Working in a matrix management environment, serve as an expert resource to project team members to oversee and facilitate the development and implementation of tools, plans and strategies for managing sites and clinical monitoring activities for clinical research projects in assigned Therapeutic Area(s) (TA). Serve as supervisor for assigned Clinical Operations staff within assigned TA. Participate as member of therapeutic core team with faculty leader, Assistant Director, and other functional group key representatives.

Supervision of Staff Activities
Serve as supervisor for assigned Clinical Operations staff within therapeutic area(s) and assess assigned staff on work assignments, utilization and productivity.
Develop written performance standards for Clinical Operations personnel.
Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.
Conduct performance evaluations for assigned staff.
Work with internal and external training resources as required; ensure that all staff assigned are current with their required training (non-study specific) including SOPs, ICH/GCP, and field-based training.
Provide development opportunities for assigned staff including coaching, mentoring and performance management.

Functional Group/ Therapeutic Area(s) Support and Strategic Planning
Coordinate the standardization and maintenance of status reports and other information sources.
Facilitate communication with external partners and key therapeutic area investigators when issues arise that affect multiple projects and/or Therapeutic Area(s).
Work with project leadership to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving regarding study progress and trial issues.
Assess overall project metrics and study timelines across the assigned Therapeutic Area (s) and assist with the coordination and prioritization of TA team efforts.
Coordinate with project leadership to identify and notify appropriate parties of emerging out of scope activities. Evaluate impact on resource needs, study processes and related documents.
Collaborate with clinical operations management and staff to identify current and anticipate long-term staffing resource needs.
Collaborate with project leadership to provide project-specific training as needed.
Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operational processes as required.
Provide input into the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.

New Business Development
Collaborate with the Therapeutic Area(s) management (faculty and Clinical Operations management), Business Development, cross-functional management, and the proposal project leader in the development of scope of work, associated budget and timelines for new business proposals (commercial and government) as required.
Represent Clinical Operations in sponsor meetings, including new business, operational meetings and sponsor audits.
Participate in scientific meetings as appropriate.

Monitoring Activities
Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on a temporary basis as needed to move project deliverables and timelines forward.
Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues. 10%

Other General Activities
Interview job candidates and make hiring recommendations for Clinical Operations positions.
Attend appropriate clinical team leadership meetings, department meetings and organizational meetings. 5%

Highy Preferred Education and Experience

Education/Training: Advanced degree preferred

Minimum of 5 years related clinical research experience including 4 years directly related clinical trials research experience to include at least 2 years clinical trial monitoring and 2 years of clinical trial lead experience. Minimum of 1 year of direct supervisory experience required.

Strongly prefer clinical research experience in therapeutic area and 3 years direct supervisory experience or an equivalent combination of relevant education and/or experience.

Knowledge, Skills and Abilities
Strong personnel management and team leadership skills
Ability to train, coach and evaluate site management and clinical monitoring team members
Ability to direct and manage competing complex individual and team clinical trial activities to meet objectives, timelines and budget
Strong technical knowledge and skills for monitoring procedures and practices
Strong knowledge of clinical research trial operations
Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
Ability to collaborate with team members to achieve trial-specific goals within specified timelines; ability to collaborate with internal and external partners to achieve departmental and organizational goals
Proficient computer skills including MS Office, Word, Excel and PowerPoint, EPM, CTMS, etc.; ability to learn and use computer applications
Ability to independently use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
Strong knowledge of medical terminology
Knowledge of scientific application to clinical trials research
Understanding of departmental SOPs and systems
Ability to travel 25%, some for consecutive nights

Preferred Qualifications
Therapeutic Experience (2 years + recent)
Multicenter trial experience (2 years)
Experience managing all phases of a trial life cycle
Experience managing multiple levels of employees
Experience managing multiple number of employees
Experience on commercial and government projects
Regulatory knowledge

Minimum Qualifications


Work requires a Bachelor's degree in Biology, Physiology, Public Health, related scientific field, or other health related field.


Work requires four years of clinical trials research experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.




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Job No:
Posted: 5/3/2021
Application Due: 8/1/2021
Work Type: Full Time